Sun Pharmaceutical Industries Ltd. announced that US FDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Sumatriptan Succinate Injection, 6 mg (base) / 0.5mL. This is the first ANDA approval for a Sumatriptan AutoInjector.
This generic Sumatriptan Succinate Injection packaged in a single-dose syringe with AutoInjector is equivalent to Imitrex STATdose System, 6 mg (base) / 0.5 mL of GlaxoSmithKline. Annual sale for Sumatriptan Succinate Injections in the US is approximately $190 million.
Sumatriptan succinate injection is indicated for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes.